Recruiting
Phase 2

Corticosteroids

Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Code:

NCT02784210

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

Prednisone

Study Details

Brief summary:

Background:

Multiple sclerosis (MS) affects the brain, spinal cord, and optic nerves. MS lesions can appear on the MRI (magnetic resonance imaging) scans in many ways. Sometimes they light up from the outer edge and fill inward. This is called ring enhancement. Researchers think this type of lesion may not heal as well as others. Corticosteroids are the standard treatment to reduce symptoms of MS relapse. But there is no standard treatment for people with enhancing MS lesions without signs of MS relapse. Researchers want to see if a short-term high-dose course of corticosteroids helps heal those lesions.

Objective:

To study the effects of short-term high-dose corticosteroids on ring-enhancing MS.

Eligibility:

Adults ages 18 and older who:

  • Have MS and a rim-enhancing lesion on a prior brain MRI
  • Are enrolled in another NINDS protocol

Design:

Participants will be screened under another protocol

Participants will be randomly assigned to get either no treatment or 3 days of treatment with a corticosteroid.

Participants will have:

  • 1 baseline visit
  • 3 days of high-dose steroids, intravenous or oral. If IV, participants will receive methylprednisolone by IV each day. Participants will also be prescribed medicine to protect their stomach.
  • Follow-up visits will be at week 13 and week 25 after randomization to treatment or no treatment.

Visits include medical history and physical exam. Participants will have blood and urine tests. Participants will also have neurological exams and MRIs. Participants lie on a table that slides into a cylinder. They are in the scanner 1.5-2 hours. They get a dye through a catheter: A needle guides a thin plastic tube into an arm vein.

...

Conditions

Multiple Sclerosis

Study ID

NCT02784210

Start date

Oct 5, 2016

Status verified date

May 8, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA:
  • Multiple sclerosis, as defined by the 2017 Revised McDonald Criteria;
  • Age 18 or older;
  • Ability to provide informed consent;
  • Able to participate in study procedures and provide high-quality clinical research and imaging data, based on limited artifacts on prior MRI scans and, when possible to determine;
  • Presence of a gadolinium enhancing lesion on the screening (3T or 7T) brain MRI that demonstrates either centripetal/rim enhancement or a phase rim, or both;
  • Simultaneously participates in another screening or natural history protocol within the NINDS Neuroimmunology Clinic at the time of study entry.
  • Willing to use birth control if able to conceive a child

EXCLUSION CRITERIA:

  • Medical contraindications for MRI (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects, or body piercings that are not MRI-compatible or cannot be removed);
  • Psychological contraindications for MRI (e.g., claustrophobia), to be assessed at the time the medical history is collected;
  • Treatment with systemic steroids in previous 30 days (non-systemic administration of steroids, such as topical or local injection, is acceptable);
  • Experiencing new neurological symptoms, with onset in previous 2 weeks, attributable to MS relapse;
  • Pregnancy or current breastfeeding;
  • Screening labs, only if required per current NIH Clinical Center guidelines for kidney-function screening before gadolinium-based MRI contrast, demonstrating estimated glomerular filtration rate <60 mL/min;
  • Known hypersensitivity to gadolinium-based contrast agents;
  • Medical contraindications to corticosteroid administration (e.g., diabetes, gastric ulcer)

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methylprednisolone

3 day course of intravenous methylprednisolone 1000 mg/day

experimental: prednisone

3-day course of oral prednisone 1250 mg/day

Interventions

Methylprednisolone

3 days of corticosteroids (intravenous methylprednisolone at 1000 mg/day

Prednisone

3 days of corticosteroids (oral prednisone at 1250 mg/day

Primary outcome measure

  • the presence or absence of a hypointense phase rim around each lesion followed over time [ Time Frame: at 13 weeks ]

Central Contacts and Locations

Central contacts

Daniel S Reich, M.D.

(301) 496-1801reichds@ninds.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Last update posted

Sep 1, 2026

Last verified

May 8, 2026

Keywords

  • Centripetal Enhancement
  • MRI
  • 7 Tesla
  • Gadolinium
  • MS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Neurological Disorders and Stroke (NINDS) on 2026-09-01.